It is desirable to provide a method and apparatus for packaging sterile solutions in pre-sterilized flexible bags to produce low cost sterile bags of solution in a non-sterile field environment.
Generally, packaging machinery produces bags of solutions through filling preformed empty bags through an opening to each bag, and then sealing the opening to produce a sealed bag of solution. Sterile bags of solution are often made through use of pre-sterilized bags, where the packaging machinery pierces the bag to be filed in a sterile manner, possibly in a sterile atmosphere, to fill and seal the bag with sterile solution while maintaining sterility of the solution and all internal bag surfaces. This method of making a bag of sterile solution requires use of a connecting methodology between bag set and filling machine that maintains sterility of the fluid filling the bag and the interior of the bag set. For many purposes, this connecting methodology is not reliable enough to ensure sterility of the bags produced to a high enough level. For example, bags of intravenous solutions for human use cannot be made this way because of the risk of contamination.
U.S. Pat. No. 4,610,790, issued September 1986, hereby incorporated by reference, discloses a method and apparatus to ensure sterile filling of bags to a high enough level that the bags will be safe for containing intravenous fluids for human use. Individual bags of sterile solution are produced through using a bag set consisting of 18 individual, flexible vinyl bags attached by means of tubing to a manifold containing 18 valves in turn attached to a sterilizing filter, all pre-sterilized after assembly into a bag set at the factory where the bag set is assembled. The sterilizing filter on the inlet to the bag set protects the internal volumes of the bags from contamination.
Individual sterile bags are produced in a non-sterile field environment by filling each bag with solution through opening a single valve in the manifold, and feeding solution through the sterilizing filter to the bag connected via the manifold. Tubes leading to the filled bags are then sealed and cut to free the individual filled sterile bags from the manifold.
This method of producing bags of fluid is inadequate mainly because the cost of the empty bag set is too expensive to make the cost of filled bags competitive with other methods of acquiring sterile bags of intravenous solution. The high cost of bag manufacture is due to the many tubes and connections that must be incorporated during manufacture of the bags. Also, the configuration of the bag set does not lend itself to being easily handled either manually or automatically.
It is therefore desirable to provide a new bag set design, method and apparatus that dramatically reduces the cost and complexity of manufacture of the bag set, yet allows these bags to be filled to make sterile bags of solution easily and automatically in the field.